Skin Carotenoid StatusNCT07198503
Study on Carotenoid-Based Instrumental Index
An observational study of Skin Carotenoid Status, run by ChinaNorm at 1 site in China.
Trial summary
Nu Skin (China) Daily-Use\&Health Products Co.,Ltd. has developed biophotonic scanners based on Raman spectroscopy, which measures skin carotenoid levels through hand skin scanning. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Carotenoid Status
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 6 Sep 2025to 16 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese individuals of Asian ethnicity aged 18 years or above.
Who may be able to join
- Chinese individuals of Asian ethnicity aged 18 years or older.
- Basic proficiency in reading and writing Chinese, sufficient to independently complete questionnaires.
- Voluntary participation with signed informed consent.
- Willingness to comply with all assessment requirements.
Who cannot join
- Presence of open facial lesions, prominent scars, or visible acne marks.
- Currently planning pregnancy, pregnant, or breastfeeding.
- Ongoing treatment for acute or severe medical conditions.
- Significant impairments affecting cognitive or behavioral abilities.
- Other medical reasons identified by experts or professionals that may interfere with the assessment results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, 200072
Sunny Sun, +86 18918961656, sunnysun@china-norm.com
About this study
Nu Skin (China) Daily-Use\&Health Products Co.,Ltd. has developed biophotonic scanners based on Raman spectroscopy, which measures skin carotenoid levels through hand skin scanning. In this study, the new Prysm device, which adopts new technology in a lower cost and more portable form, was used to measure skin carotenoid levels in a population, and the relationships between these levels and dietary habits and lifestyle factors were analyzed. The collected data included basic demographic information such as age, gender, smoking status, use of health products or nutritional supplements, and exercise habits, as well as physiological indicators such as BMI and body fat percentage. Subjective assessments were also obtained, including questionnaires on diet, skin condition, physical health, lifestyle, psychological status, and memory performance, alongside skin image analyses capturing parameters such as ITA°, L*, a*, b*, glossiness, erythema, and pigmentation.
- Conditions
- Skin Carotenoid Status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chinese citizens aged 18-50 | The study sample was selected to be as evenly distributed as possible in terms of age and gender. | |
| Chinese citizens aged ≥50 | The study sample was selected to be as evenly distributed as possible in terms of age and gender. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Carotenoid Index
The Prysm device utilizing hyperspectral absorption technology and the S3 device utilizing Raman spectroscopy technology, was used to measure the skin carotenoid index on subjects' fingers.
Measured: At a single Day 1 visit after enrollment
Body Mass Index (BMI)
BMI is derived from the subjects' measured height and weight.
Measured: At a single Day 1 visit after enrollment
Body Fat Percentage (BF%)
Measured: At a single Day 1 visit after enrollment
Demographic Information
Including basic information such as gender, age, smoking status, use of health products or nutritional supplements, exercise habits.
Measured: At a single Day 1 visit after enrollment
Dietary Intake
Subjects' dietary intake during the previous month was evaluated using Food Frequency Questionnaire - 25 (FFQ-25).
Measured: At a single Day 1 visit after enrollment
Fitzpatrick Skin Type
Measured: At a single Day 1 visit after enrollment
Skin Condition Self-Assessment
Subjects evaluated their skin condition during the previous month using a self-assessment questionnaire, covering dimensions such as photodamage, skin brightness, skin radiance, etc. Each dimension is scored from 0 to 9, with higher scores indicating better skin condition.
Measured: At a single Day 1 visit after enrollment
The score of 36-Item Short Form Survey (SF-36)
It consists of 9 different dimensions: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), Mental Health (MH), Reported Health Transition (HT). Each dimension is scored from 0 to 100, higher scores reflect better health, functionality, and quality of life.
Measured: At a single Day 1 visit after enrollment
Frequency of Physical Illness Symptoms
Subjects' immune function over the past year was evaluated using a questionnaire that collected the frequency of symptoms, including colds, influenza, allergies, etc. The total score ranges from 0 to 28, higher scores are associated with poorer immune function.
Measured: At a single Day 1 visit after enrollment
Gastrointestinal Discomfort Symptoms
Subjects' gastrointestinal discomfort over the past month, including symptoms such as abdominal pain and bloating, was assessed using a questionnaire. The total score ranges from 20 to 100, and higher scores reflect more severe symptoms of gastrointestinal discomfort.
Measured: At a single Day 1 visit after enrollment
Population-Based Visual Fatigue Scale Score
The questionnaire comprises 5 ocular symptoms (such as 'discomfort around the eyes', 'dryness of the eyes', etc.) and 6 visual and systemic symptoms (such as 'eye discomfort caused by screen brightness', 'anxiety associated with eye discomfort', etc.). The total score ranges from 0 to 44, higher scores reflect greater symptom severity.
Measured: At a single Day 1 visit after enrollment
Traditional Chinese Medicine (TCM) Constitution Classification
Subjects' body constitution was evaluated and categorized based on the Traditional Chinese Medicine Constitution Classification and Determination Self-Assessment Form, following the standards of the China Association of Chinese Medicine. For each constitution classification, scores range from 0 to 100, and higher scores indicate greater alignment with specific body constitution.
Measured: At a single Day 1 visit after enrollment
Brief Resilience Scale (BRS) Score
The BRS score is calculated by summing averaging the scores of all the six items, which ranges from 1 to 5. A higher average indicates greater psychological resilience, while a lower average indicates lower psychological resilience.
Measured: At a single Day 1 visit after enrollment
Multifactorial Memory Questionnaire (MMQ) Score
It consists of three subscales: How I Feel About My Memory (scores range from 0 to 72), Memory Mistakes (scores range from 0 to 80) and Use of Memory Strategies (scores range from 0 to 68). A higher score indicates better memory.
Measured: At a single Day 1 visit after enrollment
Facial image analysis
Including red area ratio, number and area ratio of color spots, L, a, b, and ITA °.
Measured: At a single Day 1 visit after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start6 Sep 2025
- Primary completion16 Oct 2025 (estimated)
- Study completion16 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Carotenoid StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChinaNorm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nu Skin Enterprises
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198503
- Sponsor's protocol ID
- W25002001
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Carotenoid-Based Instrumental Index
- ClinicalTrials.gov ID
- NCT07198503
- Acronym / sponsor ID
- W25002001
- Conditions
- Skin Carotenoid Status
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- ChinaNormIndustry (pharma, biotech, devices)
- Collaborators
- Nu Skin Enterprises
- Study start
- 6 Sep 2025 (actual)
- Primary completion
- 16 Oct 2025 (estimated)
- Study completion
- 16 Oct 2025 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nu Skin (China) Daily-Use\&Health Products Co.,Ltd. has developed biophotonic scanners based on Raman spectroscopy, which measures skin carotenoid levels through hand skin scanning. In this study, the new Prysm device, which adopts new technology in a lower cost and more portable form, was used to measure skin carotenoid levels in a population, and the relationships between these levels and dietary habits and lifestyle factors were analyzed. The collected data included basic demographic information such as age, gender, smoking status, use of health products or nutritional supplements, and exercise habits, as well as physiological indicators such as BMI and body fat percentage. Subjective assessments were also obtained, including questionnaires on diet, skin condition, physical health, lifestyle, psychological status, and memory performance, alongside skin image analyses capturing parameters such as ITA°, L*, a*, b*, glossiness, erythema, and pigmentation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese citizens aged 18-50 | – | –The study sample was selected to be as evenly distributed as possible in terms of age and gender. |
| Chinese citizens aged ≥50 | – | –The study sample was selected to be as evenly distributed as possible in terms of age and gender. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese individuals of Asian ethnicity aged 18 years or above.
Key inclusion criteria (4 listed)
- Chinese individuals of Asian ethnicity aged 18 years or older.
- Basic proficiency in reading and writing Chinese, sufficient to independently complete questionnaires.
- Voluntary participation with signed informed consent.
- Willingness to comply with all assessment requirements.
Key exclusion criteria (5 listed)
- Presence of open facial lesions, prominent scars, or visible acne marks.
- Currently planning pregnancy, pregnant, or breastfeeding.
- Ongoing treatment for acute or severe medical conditions.
- Significant impairments affecting cognitive or behavioral abilities.
- Other medical reasons identified by experts or professionals that may interfere with the assessment results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin Carotenoid Index
Time frame: At a single Day 1 visit after enrollment
The Prysm device utilizing hyperspectral absorption technology and the S3 device utilizing Raman spectroscopy technology, was used to measure the skin carotenoid index on subjects' fingers.
Body Mass Index (BMI)
Time frame: At a single Day 1 visit after enrollment
BMI is derived from the subjects' measured height and weight.
Body Fat Percentage (BF%)
Time frame: At a single Day 1 visit after enrollment
Demographic Information
Time frame: At a single Day 1 visit after enrollment
Including basic information such as gender, age, smoking status, use of health products or nutritional supplements, exercise habits.
Dietary Intake
Time frame: At a single Day 1 visit after enrollment
Subjects' dietary intake during the previous month was evaluated using Food Frequency Questionnaire - 25 (FFQ-25).
Fitzpatrick Skin Type
Time frame: At a single Day 1 visit after enrollment
Skin Condition Self-Assessment
Time frame: At a single Day 1 visit after enrollment
Subjects evaluated their skin condition during the previous month using a self-assessment questionnaire, covering dimensions such as photodamage, skin brightness, skin radiance, etc. Each dimension is scored from 0 to 9, with higher scores indicating better skin condition.
The score of 36-Item Short Form Survey (SF-36)
Time frame: At a single Day 1 visit after enrollment
It consists of 9 different dimensions: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), Mental Health (MH), Reported Health Transition (HT). Each dimension is scored from 0 to 100, higher scores reflect better health, functionality, and quality of life.
Frequency of Physical Illness Symptoms
Time frame: At a single Day 1 visit after enrollment
Subjects' immune function over the past year was evaluated using a questionnaire that collected the frequency of symptoms, including colds, influenza, allergies, etc. The total score ranges from 0 to 28, higher scores are associated with poorer immune function.
Gastrointestinal Discomfort Symptoms
Time frame: At a single Day 1 visit after enrollment
Subjects' gastrointestinal discomfort over the past month, including symptoms such as abdominal pain and bloating, was assessed using a questionnaire. The total score ranges from 20 to 100, and higher scores reflect more severe symptoms of gastrointestinal discomfort.
Population-Based Visual Fatigue Scale Score
Time frame: At a single Day 1 visit after enrollment
The questionnaire comprises 5 ocular symptoms (such as 'discomfort around the eyes', 'dryness of the eyes', etc.) and 6 visual and systemic symptoms (such as 'eye discomfort caused by screen brightness', 'anxiety associated with eye discomfort', etc.). The total score ranges from 0 to 44, higher scores reflect greater symptom severity.
Traditional Chinese Medicine (TCM) Constitution Classification
Time frame: At a single Day 1 visit after enrollment
Subjects' body constitution was evaluated and categorized based on the Traditional Chinese Medicine Constitution Classification and Determination Self-Assessment Form, following the standards of the China Association of Chinese Medicine. For each constitution classification, scores range from 0 to 100, and higher scores indicate greater alignment with specific body constitution.
Brief Resilience Scale (BRS) Score
Time frame: At a single Day 1 visit after enrollment
The BRS score is calculated by summing averaging the scores of all the six items, which ranges from 1 to 5. A higher average indicates greater psychological resilience, while a lower average indicates lower psychological resilience.
Multifactorial Memory Questionnaire (MMQ) Score
Time frame: At a single Day 1 visit after enrollment
It consists of three subscales: How I Feel About My Memory (scores range from 0 to 72), Memory Mistakes (scores range from 0 to 80) and Use of Memory Strategies (scores range from 0 to 68). A higher score indicates better memory.
Facial image analysis
Time frame: At a single Day 1 visit after enrollment
Including red area ratio, number and area ratio of color spots, L, a, b, and ITA °.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Carotenoid Status, run by ChinaNorm at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Carotenoid Index (time frame: At a single Day 1 visit after enrollment). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.